Lorcaserin is the subject of an exclusive licensing agreement concluded between Eisai’s US Subsidiary Eisai Inc and Arena Pharmaceuticals GmbH, the wholly-owned Swiss subsidiary of Arena, concerning its commercialisation in the US.
Lorcaserin, which Arena discovered and has developed, is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese and have at least one weight-related co-morbid condition.
The FDA outlined the non-clinical and clinical reasons for their decision, in the complete response letter.
The non-clinical issues identified by the FDA are the safety issues related to the rat carcinogenicity study, while with respect to the clinical reasons, the FDA recommended that Arena submit the final study report of the BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial.